Interferential Current Therapy After Total Knee Arthroplasty

Is Interferential Current Effective in the Management of Pain, Range of Motion, Edema Following Total Knee Arthroplasty Surgery?: Randomized Double-blind Controlled Trial

Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. So this study is aimed to investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. In this study interferential current compared with sham interferential current . Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Interferential Current; Device: Sham Interferential Current

Detailed Description

A total of 132 patients ranging in 60-85 years who were undergoing their first total knee arthroplasty due to knee OA were recruited into a randomized, double-blind, prospective and controlled study. Participants were recruited at the Orthopedics and Traumatology inpatient clinic. The patients were seen postoperative first day and were assigned to receive either interferential current or sham interferential current by block randomization. After the procedure was explained to each subject, interferential current treatment was applied 2 times for 5 days, each treatment was continued approximately 30 minutes. Four electrodes were used to deliver quadripolar interferential current Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current treatment consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes. At the same time, all patients received standard postoperatively rehabilitation program. Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35030
      • Ege University School of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

•Patients who underwent total knee arthroplasty surgery

Exclusion Criteria:

• Patients who had experienced of any electrotherapy prior to the TKA to be sure blinding of therapy
• Patients who had history of any contraindication for electrotherapy
• Patients who had chronic pain rather than knee OA
• Patients who had experienced a known or suspected joint infection or a specific condition (ie, peripheral or central nervous system lesions, neoplasm, diabetes mellitus, osteonecrosis, recent trauma and pacemaker)
• Patients who had history of stroke, central nervous disease, mental impairment or poor general health status that would interfere with functional assessments during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Interferential Current Treatment; Interferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery.	Device: Interferential Current
SHAM_COMPARATOR: Sham Interferential Current Treatment; In the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time.	Device: Sham Interferential Current

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain from baseline measured by visual analog scale	Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)	Change in pain measured 5th and 30th days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Range of Motion from baseline	The measurement of the range of the motion was performed by a goniometer of active extension and flexion (higher values represent better outcome)	Change of Range of Motion measured 5th and 30th days after surgery
Change of Edema from baseline	Edema as a change in circumference from the preoperative value was measured by a meter (higher values represent worse outcome)	Change of Edema measured 5th and 30th days after surgery
Amount of used paracetamol	the paracetamol intake was recorded as gr. (higher values represent worse outcome)	5th and 30th days after surgery

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: mehmet r kadı, MD, Ege University School of Medicine; Study Director: Simin Hepguler, prof, Ege University School of Medicine; Study Chair: Funda C Atamaz, prof, Ege University School of Medicine; Study Chair: Emine Dede, md, Ege University School of Medicine; Study Chair: Semih Aydogu, prof, Ege University School of Medicine; Study Chair: Kemal Aktuğlu, prof, Ege University School of Medicine; Study Chair: Nadir Ozkayın, prof, Ege University School of Medicine; Study Chair: Cihat Ozturk, prof, Ege University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; surgery; total knee arthroplasty; interferential current
• Other Study ID Numbers: TKP35IF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No